Robert Schneider, MD, director of the Institute for Natural Medicine and Prevention and dean of Maharishi College of Perfect Health in Fairfield, Iowa. Courtesy MAPI

Updated– Last year, in what may have been an unprecedented action, a paper on the effects of Transcendental Mediation (TM) in African Americans was withdrawn by the editors only 12 minutes before the paper’s scheduled publication in Archives of Internal Medicine. No definitive explanation was ever provided, though the editors and authors said that the action was prompted by last minute questions from reviewers at the NIH, which helped fund the study. (The episode was covered in detail on CardioBrief (here and here) and on RetractionWatch.)

Now a new version of the paper has been published in Circulation: Cardiovascular Quality & Outcomes. The first author is Robert Schneider, from the Institute for Natural Medicine and Prevention at Maharishi University of Management in Maharishi Vedic City, Iowa. The co-authors are from the same institution and from the department of medicine at the Medical College of Wisconsin in Wisconin. It is clearly the same study of 201 African American patients randomized to TM or health education (HE) and followed for 5.4 years, though some of the numbers have changed in important ways between the earlier and later publications. One change involves the primary endpoint: the new paper in Circ:CVQ&O reports 52 primary endpoint events (the composite of death, MI, or stroke). Of these, 20 events occurred in the TM group and 32 in the HE group. By contrast, in the previous Archives version there were 51 primary endpoint events: 20 in the TM group and 31 in the control group.

In both papers the difference in the primary endpoint did not achieve statistical significance until after the investigators adjusted for baseline differences. The unadjusted hazard ratio (HR) for the new study was 0.64, (confidence interval 0.3701.12, p = 0.12); after adjusting for age, gender, and lipid lowering medications the HR drops, presto-chango, to 0.52 (0.29-0.92, p=0.025) and achieves statistical significance..

Dome shaped building on MUM campus, for the group practice of the TM-Sidhi program and Yogic Flying (Photo credit: Wikipedia)

Here are some other key questions that I have asked AHA, Circulation editors, and other experts to address:

— Was the AHA or the Circulation staff aware at any time that an earlier version of this paper had been scheduled for publication in Archives of Internal Medicine and withdrawn only 12 minutes before the scheduled publication time? Should this information have been disclosed by the study authors when submitting the paper?

— As mentioned above, the original publication in Archives appeared to have been cancelled because of questions raised by NIH reviewers. Have the Circulation: Cardiovascular Quality & Outcomes editors received any assurance that these questions have been addressed in the new paper?

— This trial was started all the way back in 1998 but was not registered on ClinicalTrials.Gov until February 2011 (shortly before the intended Archives publication). Why was it not registered earlier than 2011?

— June 2007 is listed in ClinicalTrials.Gov as the final data collection date for primary outcome measure. Why are the primary endpoint numbers different between the Archives and new version of this paper?

Update, November 13-– Harlan Krumholz, the editor of Circulation: Cardiovascular Quality & Outcomes, sent the following statement:

“We had no prior knowledge of what transpired with the Archives of Internal Medicine. The Schneider paper went through rigorous peer review, statistical review and editorial discussions and the authors of the article were responsive to the review process. As a result, the paper was accepted for publication and we are going ahead as planned. If you have any further questions, we suggest you contact the researchers directly.”

Update, November 18– An earlier version of this article contained several mistakes. First, the difference in the number of primary endpoint events between the two papers is much smaller than I had stated. The original paper reported 51 primary endpoint events. The new paper reports 52 endpoint events. I am still unclear about why there should be any difference between the two, since, as mentioned above, June 2007 was the final data collection date for the primary endpoint. I also incorrectly claimed that some data reported in the original Archives paper were not included in the new paper. In fact, as a reader pointed out in the comments section below, these data were reported in Figure 1. I apologize for this mistake and regret the error. –LH

I asked Sanjay Kaul for his perspective on the paper. Here are his points:

1. All cause mortality constituted nearly 80% (41 of 52) of the primary composite endpoint. This is highly unusual as most trials yield a higher proportion of nonfatal events compared with fatal events. This leads me to question the fidelity of the adjudication process to pick up nonfatal events.

2. It is difficult to attribute a nearly 50% reduction in hard CV outcomes to a <5 mm Hg difference in systolic BP. Total anger was significantly reduced, but attributable risk of anger or emotional distress for MI or death is very small.

3. It is interesting to note that the study was originally powered for a 36% reduction in a broader endpoint, but a larger 50% reduction in the revised narrower endpoint. This is difficult to justify.

4. It is not clear if the adjusted analyses were adjusted for multiple comparisons. Given the wide CI and less than robust P value, it is likely the results would be no longer significant.

5. Even if one accepts the adjusted p value, the strength of evidence is not robust.

Disclosure: I work closely with the editor of Circulation: Cardiovascular Quality & Outcomes, Harlan Krumholz, on the CardioExchange website. Harlan has had no editorial control or input on this story, though I have contacted him, and other AHA officials and additional experts, for comment and perspective about this story.

34 comments

the paper wasn’t pulled due to questions but due to inclusion, at the last minute, of data that had accumulated by the time the paper had passed the review process, at the suggestion of one of the reviewers:

PR issues, I would think. It looks like the publication cycle for the second journal is much faster than for the original, and if they wanted to see it published any time soon, they had to go with the faster journal.

The primary effect of Transcendental Meditation is to bring about a deep and unique physiological state which has been called “restful alertness”. This state of deep rest provides a milieu in which the nervous system can systematically release stored internalized stresses, acquired in daily life through sensory and cognitive experiential overloads. As a result of this ongoing stress release from TM, many measurable benefits occur in mind and body. These benefits occur because stored stress causes systemic dysfunctions; the release of these stored stresses eliminate the dysfunctions.

Some of the improvements in mind and body caused by TM are easy to measure. The reduction in both state and trait anxiety, for example, are highly significant and have a robust effect size, based on psychometry using the STAI inventory. Simple statistics suffice to show the dramatic improvement that TM quickly brings to both state and trait anxiety.

However, the various ways to show improvement in cardiac and circulatory function and health have a much lower significance and effect size, because the role of stress is less of a primary factor in causing morbidities and mortalities in this area. For this reason, the experimental design must be more sophisticated to pick up the effects.

Whenever designs are more complex, there is more to go wrong, and more that can be criticized. For this reason, one paper may not be sufficient to indicate a measurable causative relationship. The entire literature in the cardiac and circulatory effects of TM should be considered, and an accurate assessment for reliability may need delay as studies continue to be conducted and replicated in this area.

I think Mr. Husten doesn’t protest enough. I have been meditating for nearly 40 years, I used to work for the TM movement and I can tell you plainly that you can count on the TM people to engage in any sort of shell game they think will get people to meditate.

They leave quite a lot out too. I realize the article is about one aspect of TM’s effects, but let’s also talk about the fact that there are many many long term practitioners of TM who become basket cases emotionally and in some cases mentally. Let’s talk about the number of long term TM’ers who have committed suicide like my friend Mark Totten who stepped in front of a train on the TM University’s campus in Iowa.

It is a shame that the David Lynch people are in collusion with the TM people to give a legitimacy to an organization that doesn’t deserve it. I know what TM and the people who promote it are like – I leave the science to the scientists and hope that those who have NO affiliation with TM will review all the so-called studies that the TMO creates and tell the rest of us what objective science says about TM.

Let’s have freedom of choice – if people want to do TM, let ’em do it, but let them have the full story about TM and the TM organization first.

Michael, There are quite a few individuals who, probably disillusioned either by their failure to reach enlightenment, which they thought was promised to them by the TM organization, or by changes that they perceived in its leader, Maharishi Mahesh Yogi, or by simple misunderstandings about the nature of stress release, not only have left the fold of TM supporters, but actively work against it in anti-TM blogs and organizations. I don’t know if you are one of them. These people, while clearly having a chip on their shoulder, as you do, write very convincingly of the supposed evils of transcending.

As evidenced by the name of the organization founded by his sister to help others, Mark Totten was suffering from clinical depression when he suicided one year ago. Perhaps someday Maharishi University of Management (MUM) will screen out people with mental illness, but to date all the violence demonstrated by TM meditators has been in those suffering from mental illness.

TM is not a cure for any form of mental illness, or physical illness for that matter. It is a natural fourth state of consciousness, useful for normal people to grow in maturity, to drop unwanted bad habits, to gain in energy, focus, and love. It is not intended for use by those with mental illness, and is not responsible for misuse by anyone with a serious pre-existing life problem. In my professional experience with a number of mentally ill people who practice transcending, they must continue to follow their doctors’ instructions to have good results. In addition, they must be very patient, as dealing with the deep stresses of mental illness can take many, many years of modified TM practice.

As to meditating for 40 years, I have been practicing TM for 42 years, including TM teacher training by Maharishi Mahesh Yogi for 8 months in residence. I have never had a harmful result from my personal practice, or heard of a harmful result by my 100 TM students or by my 1500 NSR students. On the contrary, I find every meditation session to be restful and invigorating. If you find bad effects from TM you should either get your meditation checked so that you practice it correctly, engage in useful and life-supporting activity to make use of your reduced stress level, or stop meditating. No one should do something that makes them suffer.

As anyone who has learned transcending will attest, transcending is completely simple, natural, and effortless. It should be clear to anyone practicing TM that by itself it cannot create any effects other than relaxation, a reduction in mental chatter, or other forms of reduction of internal, stored stresses. I would be happy to continue this discussion off-line with Michael or anyone else who may be interested. I have only scratched the surface of my response here, as I see this topic to be tangential, and adequate discussion really requires a dialog, which is not appropriate here.

A- I never said a word about the “evils of transcending” those are your words and they are an incorrect assumption.

B – I still use my TM mantra sometimes and have also enjoyed the benefits of other kinds of meditation.

C – I am not telling anyone not to meditate – I am just saying stay away from TM because of the baggage it carries from Maharishi and his dishonest organization.

D – In your support of TM you also tacitly promote your own brand of meditation.

E – On your own Natural Stress Relief website you show people why they should learn to meditate from you instead of from the TM people. If TM is so great, why aren’t you still a TM teacher?

F – Mark Totten did not commit suicide last year – he did it in 1992. When I knew him at Maharishi International University as it was then called, he was a calm, well balanced and very likeable individual, and exhibited no signs of mental illness – from people who were around him in 1992 all reports were that he was absolutely one-pointed on the program, went to group program regularly, etc.

G – When you state that TM doesn’t have any negative effects you are either being willfully ignorant or flat out dishonest, unless you are following in the footsteps of the TM researchers and cherry picking your information.

If you mean that people who only meditate 20 minutes twice a day never have problems you may be correct, yet if you include people who go on extended TM meditation courses like you did on your TM teacher training, you know damn good and well that lots of people have had problems on such long meditation courses. If you don’t know about the very common TM phenomenon called “unstressing” you are the only former TM teacher who doesn’t.

H – I only want people to know the facts and make informed choices.

Fact – I do think the basic TM technique is a decent meditation, no better and no worse than any other meditation except for the fact that you have to deal with a dishonest organization that exists purely to separate people from their money. (I freely admit that is my opinion.)

Fact – Even here on a blog devoted to medical knowledge when you are talking anything about TM, you have to deal with the whole ball of wax. The behavior of Maharishi and his organization’s leaders make it unavoidable.

Fact – TM is an organization whose leaders wear gold crowns and call themselves “rajas”. Each so-called raja paid exactly one million dollars to Maharishi when he was alive for their raja training.

These same people promote a form of architecture called “Vedic Vastu” that claims among other things if people live and work in a home or office with a south facing entrance they people will have continual health, emotional, relationship and financial problems.

They took this so seriously that after Maharishi started putting this forth as truth, officials at their University in Fairfield, Iowa began locking all doors that faced south in all campus buildings even in violation of safety and fire codes – and you expect anyone to take anything these people do as scientific and take them seriously?

Fact – I did not stop being a TM supporter for any of the reasons you stated in the beginning of your comments. I stopped because of the BEHAVIOR of the leaders of the TM movement. Their behavior has been remarkably consistent over all the years since I began meditation in 1974 to the present time.

They and their Maharishi have engaged in deceptive, manipulative and at times downright abusive behavior and that includes manipulating the information they present in their “scientific” studies. Then using their own manipulated date then call all their programs “scientifically proven technologies”. One doesn’t expect such behavior from people who have been practicing a technique with such wowie zowie results that you attribute to TM.

Fact – No matter what you say, the TM people in collusion with the David Lynch Foundation are creating an orchestrated blitz of the public’s attention to get people interested in meditation. Katy Perry asking for donations to the David Lynch foundation, Bob Roth (longtime TM spokesperson) being interviewed by Soledad O’Brien, and many articles such as the one that was talked about on this blog. It is all being put forth to get people meditating.

Fact – the TM organization is interested in getting new TM meditators so they can begin to woo them to participate in all the “advanced programs”. I simply feel the public that is being courted in this shady fashion needs to know the qualities of the suitor knocking at the door with roses and a toothy smile.

This isn’t a fact, but I don’t presume determine what comment should be posted here – I leave that to the moderator of this blog.

There is so much wrong with David Spector’s posts that it’s hard to know where to begin. One thing I have learned about TM teachers is that they are BIG talkers. It’s like if they just keep spewing and spewing and spewing this stuff, they will make it true. There is some truth to this technique of spewing to make it true–it’s called brainwashing.

I have taken the TM course and I meditate twice a day for 20 minutes using a mantra and the “TM” technique. My objection is to the branding and the cult surrounding TM. It is no more than meditation as practiced from millenia by people of many different racial ethnic religious and cultural persuasions without paying a thousand bucks to learn it. The TM movement’s approach to science is very much the same as the talk ’em death approach. They just spew out these endless confusing “scientific” facts and hope you’ll just give in by their persistence. I am a brain scientist, and I have reviewed the science on a number of occasions (every time I get tired of arguing about it with TMers, I go back to the literature to see whether I’m missing something). I am just not buying it. The science is seriously biased and flawed. TMers will talk like there is a conspiracy against there science. In truth, their science is not necessarily worse than a lot of other bad science out there, but it is still bad science. If a non-TMer does a study on TM and finds no differences from comparison groups, then (just like some other practices with a cult-like flavor to them that I have studied) the TMers claim that IT was bad science because they can’t have possibly implemented the practice correctly. So TM can never be shown to have no effect because only TM cultists can do the studies.

I am a big believer in meditation (of any sort, not just TM) and I know and love many TMers. But I cannot abide bad science for any cause, and I believe it is a disservice to a spiritual practice to cloak it in such.

You express a lot of negative opinions, “Michael H Jackson,” but there is no evidence or any real-world truths for your condemnations of TM and the foundation that teaches it. For example, “the many long-term practitioners of TM who become basket cases”—there is zero empirical data to support this, and in fact all the research ever done on TM shows completely opposite, all-positive results. See: Myth #9: Meditation can have bad side effects and make you crazy! http://meditationasheville.blogspot.com/2010/12/myth-meditation-can-have-bad-side.html

Tammy some of what I have written are my opinions and some are facts. If by empirical data you mean there are no scientific studies on the people who have problems from long term TM practice, especially those who start heavy “unstressing” on long rounding (meditation) courses you are correct.

You are correct on that point because most scientists who don’t do TM don’t waste their time studying it and those who practice TM are too cowardly to study anything that might resemble a negative effect of TM because to do so might tend to curtail their gravy train since the only scientists who do these studies are the ones who live and work for the TM Movement.

If as I suspect you are a long term TM meditator and TM teacher Tammy, you know as well as I do that there are lots of people who have stopped doing TM and lots who had problems on TM courses.

If you want to play dueling banjos about this, I am more than willing to contact some of them and ask them to post a few of their stories on this blog if the moderator thinks its appropriate.

I have been forthcoming about my former affiliation with the TM Movement – how about you Tammy? How long have you been doing TM? How long have you been a TM teacher? And who was it that asked you to post a rebuttal to my comments? Tony Nader? Bob Roth? Bevan? John Hagelin? Or was is Bobby Schneider himself?

As I said to David Spector, a former TM teacher who waxes lyrical about TM even though he wants people to do his brand of meditation rather than TM, I don’t care if people do TM or not – I just want them to have the facts about the organization that teaches it so they can make an informed decision.

I freely admit I sometimes still use my TM mantra – the technique is a classic mantra meditation from India where mantras and meditation techniques are common. TM is neither better nor worse than any other.

I no longer support the TM Movement with my time, effort, energy, money and consciousness because of the behavior of those who run this TM organization. And if you think that some of the TM “scientific” studies are on point such as those that claim that large groups of “yogic flyers” can reduce crime rates, suicide rates and even create world peace, I think it would be pertinent to this conversation for you to admit it.

One should always be skeptical of any medical or other practice that finds “all-positive” results. I am a brain scientist myself (Ivy-league educated and highly regarded). There is nothing under the sun that is “all-positive.” To come across something that makes those claims is to know for sure that there is a cover-up.

Ken, One must assume good intentions on the part of authors who evidently do not have the full story and are prone to excitement or exaggeration. On the other hand, the world is full of scams, even good and authentic-sounding scams. I don’t really blame anyone for being suspicious of Transcendental Meditation, since it promises so much, yet is so easy to learn and practice.

The road to acceptance can a very long one. Those, like you, who are offering this practical and effective technique to the world, need to have a great deal of patience and acceptance along the road you have chosen. I am completely convinced that TM will eventually find complete acceptance by all the practitioners and institutions of medicine, including universal recommendation as the primary means of preventive medicine. I wouldn’t be surprised if some enterprising insurance companies don’t soon offer TM tuition as a preventive medicine benefit.

Frankly, the accumulated research evidence supporting the effects and benefits of TM is sufficient already to convince any open-minded, educated person of the physical and mental health benefits of TM, along with the remarkable lack of unwanted side effects. It is just a matter of time until the uninformed objections and skepticism die down and allow TM to take its rightful place as one of the cornerstones of a healthful and progressive society.

Perhaps it would help if readers would consider TM to be an example of a generic mental technique, which we could call simply “transcending,” instead of the trademarked term “Transcendental Meditation.” By viewing transcending as a natural state of consciousness, as natural as waking, dreaming, or sleeping, acceptance might be easier. One might have objections to a proprietary technique, perhaps based on the fact that only one organization handles the financial aspects, but such objections disappear when the technique is considered as generic, and taught in more acceptable ways.

For example, Natural Stress Relief (NSR) is a very different approach in which people teach themselves transcending from a manual, mailed to them, for not much more than the cost of printing. Nothing could be more generic. Yet published research shows that NSR reduces both state and trait anxiety as effectively as does the full-scale TM course. It also shows the same pattern of immediate EEG and skin resistance effects during practice. Clearly free of any profit motive, as well as of any religiosity or mysticism, NSR serves as an example of how a generic approach can bring the benefits of transcending without irritating those, including decision-makers in society, who are fearful of grand claims only because they are new and unfamiliar.

The existence of NSR can serve as an inspiration for those teaching TM, because it proves that the elimination of those aspects of the TM message that alienate people is possible and practical.

2) A new study with a new purpose is called prospective using old data from a previous study. If one prospective study generates a new question (survival) a complete new study should be performed with the new hypothesis, everything else would be to cook soup on an old bone several times.

The accusations of manipulating data are completely unfounded, as far as I can see. Where is there any evidence at all to support that? It’s just negative speculation. The “$20M” from the NIH is not a conflict of interest. The grants were awarded to teams of scientists, not all to Dr. Schneider, and all of that funded research also involved scientists not associated with the University where Schneider is employed. It is not a new study with a new purpose. It is the original study that included the data that did not come in in time for the first submission to Archives.

This is a compelling and important study. It has gone through far more scrutiny and peer-review analysis than studies usually do, and no design flaws were identified. There is also a strong precedence of solid research on TM in many other areas, especially cardiovascular, that supports the theoretical basis for TM’s positive effects on cardio health and mortality.

There’s a fine line between healthy skepticism (which can play a natural role in the scientific process) and cynical bias, which can cloud one’s judgement and obstruct a fair appraisal of a research study. It seems the important questions here are, did the TM protocol really produce the results that the study’s findings suggest? Does the research design control for variables sufficiently, and does the data support the findings?

No definitive explanation was ever provided for the pulling of the first study. This article’s insinuation is clearly that the first study was somehow tainted, but the article provides no evidence or reasoning for that. I think a more likely cause for Archives withdrawing the study “without explanation” was that they just got cold feet about publishing a study on meditation that showed an alternative protocol radically outperforming conventional medicine. Perhaps the same kind of bias at work in this article was behind the pulling of the first paper.

Another key to identifying scientific cover-up is Tammy’s statement that “no design flaws were identified.” As a brain scientist for the past 20 years, I can attest to the fact that the perfect study with no design flaws does not exist. Rule one of publishing–you must identify your design flaws yourself in your conclusions–we call them “limitations of the results.” The problem with the TM movement is that they refuse to ever see any even tiny flaw in anything about TM. It hurts their credibility. I would like to ask these “objective” scientists what other promising practices they have identified and studied? If TM is the only thing they can come up with to solve all of the world’s problems, then it is just not credible. I practice transcendental meditation. I purposely spell it using the lower case, even though I have been trained by the upper case movement. Upper case TM is a cult. Lower case tm, which you can learn through a variety of spiritual teachers other than the TMers, is a valuable addition to anyone’s life practice.

“The paper reports on 52 primary endpoint events (the composite of death, MI, or stroke). Of these, 20 events occurred in the TM group and 32 in the HE group. By contrast, in the previous Archives version there were 12 fewer, or 40, primary endpoint events: 17 in the TM group and 23 in the control group.”

NOT SO. THE ARCHIVES VERSION REPORTS 20 EVENTS IN THE TM GROUP AND 31 IN THE HE GROUP, SEE TABLE 2.

“In both papers the difference in the primary endpoint did not achieve statistical significance until after the investigators adjusted for baseline differences. The unadjusted hazard ratio (HR) for the new study was 0.64, (confidence interval 0.3701.12, p = 0.12); after adjusting for age, gender, and lipid lowering medications the HR drops, presto-chango, to 0.52 (0.29-0.92, p=0.025) and achieves statistical significance.”

THIS IS COMMON PRACTICE IN STATISTICAL ANALYSIS, ESPECIALLY WITH BEHAVIORAL HEALTH STUDIES.

“The new version of the paper fails to include some key information from the earlier report, including: Although 201 patients are reported in the analysis, the study assessed 451 patients for eligibility and randomized 213 patients.

NOT SO, FIGURE 1 CLEARLY REPORTS THESE DATA IN FIGURE 1.

“12 patients– 6 in each arm– were randomized but then excluded because they did not meet the trial’s inclusion criteria.”

AGAIN NOT SO, THE DATA ARE CLEARLY SHOWN IN FIGURE 1.

“41 patients– 20 in the TM arm, 21 in the control arm– were lost to followup.”

AGAIN, NOT SO, ALL LOST TO FOLLOW-UP CASES ARE REPORTED IN FIGURE 1

“This trial was started all the way back in 1998 but was not registered on ClinicalTrials.Gov until February 2011 (shortly before the intended Archives publication). Why was it not registered earlier than 2011?”

“June 2007 is listed in ClinicalTrials.Gov as the final data collection date for primary outcome measure. Why are the primary endpoint numbers different between the Archives and new version of this paper?”

“THE NUMBERS ARE ONLY SLIGHTLY DIFFERENT AND THE OVERALL PATTERN OF FINDINGS IS VERY SIMILAR. AS NEW DATA EMERGED, THIS MAY BE ATTRIBUTED TO THE PEER REVIEW PROCESS OF THE DIFFERENT JOURNALS.

“1. All cause mortality constituted nearly 80% (41 of 52) of the primary composite endpoint. This is highly unusual as most trials yield a higher proportion of nonfatal events compared with fatal events. This leads me to question the fidelity of the adjudication process to pick up nonfatal events.”

THIS IS THE FIRST PROSPECTIVE MORTALITY TRIAL WITH A MEDITATION TECHNIQUE. THE INCLUSION/EXCLUSION CRITERIA WOULD SUGGEST THAT THE ENDPOINTS REPORTED ARE REASONABLE.

“2. It is difficult to attribute a nearly 50% reduction in hard CV outcomes to a <5 mm Hg difference in systolic BP. Total anger was significantly reduced, but attributable risk of anger or emotional distress for MI or death is very small."

THE REDUCTION IN ENDPOINTS SHOULD NOT BE SOLELY ATTRIBUTED TO THE BP CHANGE.

"3. It is interesting to note that the study was originally powered for a 36% reduction in a broader endpoint, but a larger 50% reduction in the revised narrower endpoint. This is difficult to justify."

THE STUDY EXCEEDED EXPECTATIONS IN THAT A LARGER REDUCTION WAS OBSERVED THAN PREDICTED.

"4. It is not clear if the adjusted analyses were adjusted for multiple comparisons. Given the wide CI and less than robust P value, it is likely the results would be no longer significant."

THE PRIMARY ENDPOINTS WERE ADJUSTED FOR STRATIFICATION VARIABLES (AGE, SEX, AND LIPID-LOWERING MEDICATIONS, FOR THE PRIMARY ANALYSIS.

"5. Even if one accepts the adjusted p value, the strength of evidence is not robust."

THE P VALUES FOR THE ADJUSTED VALUES ARE .025, .04 AND .03 WHICH ARE ALL STATISTICALLY SIGNIFICANT.

Tammy, thank you for carefully reading this and pointing out several errors. I have corrected the story and added an update notice. Here is my response to your points:

1. You are correct that I wrongly reported the difference in the endpoint numbers between the two papers. This has been corrected.

2. It is highly debatable whether it is common practice to adjust for baseline differences in randomized clinical trials. The entire point of a randomized trials is to test a hypothesis in two equal groups. The problem with this trial is that there were far too few patients randomized, thus leading to an almost inevitable imbalance of important baseline characteristics. Statistical methods to adjust for these differences should always be treated with extreme care. If only for this reason, any conclusion from the trial should be considered, at best, hypothesis generating.

3-5. You are correct that the data I reported as missing in the new paper were in fact reported in Figure 1. I apologize for this error and have removed the offending paragraph.

6. Regarding registration on ClinicalTrials.Gov, I think any trial with cardiovascular endpoints does, by definition, “involve a serious or life threatening disease or condition,” and so the trial should have been registered earlier.

7. Since both papers were submitted well after the June 2007 date for final data collection there should be NO difference between the two papers in this regard. I regret that I reported a larger difference than actually exists, but ANY difference is still a cause for concern. There may of course be a perfectly innocent reason for this discrepancy, but it should have been fully reported and explained in the second paper.

8-12. This was NOT a prospective mortality trial. Not even close. Any hint of a survival benefit must be considered hypothesis generating. I don’t want to get into a detailed argument about the statistics, but any knowledgeable, objective reader would conclude that these results are at best suggestive of a possible benefit. This is NOT a robust trial with convincing results. Any attempt to portray these results as truly convincing is mistaken.

Dear David,
I have read with interest the exchange between you and a friend of mine, Michael H. Jackson, and felt I just had to comment – my first on any kind of blog whatsoever. I’ve also been meditating about 40 years, most of that time as a Sidha, and still regularly do my program. I just wanted to make a brief comment concerning a small portion of your initial response to Michael:
“Michael, There are quite a few individuals who, probably disillusioned either by their failure to reach enlightenment, which they thought was promised to them by the TM organization…”
I distinctly remember being told in my checking sessions after being initiated that enlightenment would take “4-6 years”. I learned the Sidhis several years after, and was told that the Sidhis were “10,000 times more powerful than regular meditation”. In addition, in Maharishi’s commentary on the Gita he give the impression over and over that gaining enlightenment through TM is not difficult. You may say that all this is not the promise of enlightenment, but I don’t think this is being honest.
I am not enlightened, have never met anyone who is, and would bet that you are not. I still meditate simply because of the practical value of the technique, I can honestly say that the practice has made me much more available as a loving husband and father to my 3 sons (neither my wife or sons meditate). I have also learned in recent years that it is ok to miss a program here or there in order to nurture the family and other important relationships in my life – in other words, I’m a lot more relaxed about the practice and and no longer got the hammer down at the expense of all else in order to win this “race to inner space”.
I agree with you that a lot of the negativity about the movement is sour grapes about not reaching enlightenment, but a lot of it is also response to the TM leadership. There seems to be an inverse relationship between a person’s position in the movement and their general ability to relate in a normal, human way. There are a few exceptions to this rule, but very few. If the upper echelons of the movement were an inexcapable indication of where TM is taking us, then I would quit today.
Bill Kossler

I love this sentence from Bill Kossler: “There seems to be an inverse relationship between a person’s position in the movemetn and their general ability to relate in a normal, human way.” It made me laugh because it is so true. I was moved to try TM (capital T capital M PLEASE!) by simple meditators whose personal testimony was compelling in it’s simplicity. I false started many times because I had such a hard time getting past the bogus science presented at the introductory meetings (I am a brain scientist, high level, and am very put off by bad science). My own practice remains strongest the further I stay away from the movement. When people start haranguing me with bogus arguments, I shut down and naturally rebel. Please, TM teachers, stay away. Ordinary practitioners who are willing to speak GENUINELY about their experiences, let’s chat.

Chrissy – This might be of particular interest to you since you’re a neurologist. I took the course in TM in May 2012. I had bizarre experiences from the start and had to quit after barely a couple weeks because of the adverse effects it had on me.
This is a brief story (okay, so it doesn’t look brief but if you knew how long the story actually is, this IS brief) of what happened. The very first session, I had pains/pressures in the right side of my head and a weird sensation throughout the right side of my body. By the 4th day of the workshop, I ran out into the hall at the beginning of the group meditation session because my eyes had clenched shut, and I couldn’t open them for a bit. I lay out in the hall on the ground with sharp pains in my head like a knife being dragged down the side of my face. My entire body was shaking, my muscles tense, and sobbed and cried uncontrollably. I was instructed to meditate only for 5 minutes instead of the full 19 minutes. The shorter meditation sessions, however, did not help as it got to the point where all this stuff would start happening shortly after closing my eyes to meditate. I stopped meditating after a particular session where I experienced very painful facial contortions for 3 hours after the meditation session was over. Unfortunately, stopping meditation did not stop these symptoms because they surfaced whenever I was relaxed (not trying to meditate), whenever I’d get stressed, and they even happened at random. My symptoms became full-blown in July at summer camp after giving meditation another shot, and I had what superficially looked like convulsions and could not walk without assistance afterwards because my abdominals were clenched so tight, I was hunched over more than 90 degrees (that occurred on and off for for nearly a week before having another attack, that time more severe). The doctor at camp informed me it was conversion disorder (neuropsychiatric illness in which stress/emotions are not properly processed causing physically unexplainable involuntary motor/sensory symptoms), gave me ativan (which actually helped, the symptoms vanished for a number of hours but came right back after it lost its effect) ,and told me to see a psychiatrist when I got home. I told my meditation teacher about it, and at first he believed it was a spiritual experience, a kundalini experience, but after e-mailing him a video of part of an attack, he was shocked as he’d never seen such a violent reaction to meditation and told me to go see a doctor.
I’ve had a variety of symptoms since then that have affected me for much of the day most days including speech problems, dystonia (limbs locking up, facial contortions, full body contortions), pains all over my body, extreme mood swings, gait problems, convulsions, episodes of hysterical screaming and flailing/thrashing (which can last up to 3 hours), uncontrollable hysterical laughing and other verbal outbursts, abnormal body movements, tics, tremors, insomnia, derealization, panic attacks, chronic anxiety, paralysis, and the list goes on. I had never before in my life had motor problems before taking the TM course.

I wasn’t involved with the organization long enough or knew enough about it to have anything against them, but I am against dishonesty. I’m rather perturbed because of the organization’s false advertising, claiming that there are NO negative side effects, and yet they discuss the negative side effects AKA destressing after you pay for the course. And anything negative is portrayed as something positive and desirable (which I guess if that’s how you choose to view it, then there are no ‘negative’ effects) and thus encouraged. There is nothing glamorous about being plagued daily by debilitating neuropsychiatric symptoms at 19 years old. “Destressing” shouldn’t cause you more stress than is being “released” and more stress than you have experienced in your lifetime.
While I realize I am likely one of the rarer/extreme cases, I can’t possibly be the first who has had a negative experience, and I know I am not because I’ve discovered testimonies from others regarding adverse effects of TM.
Yes, TM has amazing effects for many people, but the minority of those who experience adverse effects (and there are probably many more who experience milder negative effects) shouldn’t be swept under the carpet to be ignored or denied a voice because they might blemish the rep of the organization and the claims of their scientific research.

Carissa–I hope I can reply to you (there is no reply link on your posting). I have had some success in cases of out-of-control unstressing such as yours (these happen for about one out of one thousand students of transcending techniques, an extremely low incidence). Please contact me using the Contact Us page at http://www.nsrusa.org.

Actually, quite a few people are at least somewhat enlightened via TM. The definition of [the first kind of] enlightenment via TM is that the physiological changes that take place during TM have become a sufficiently noticeable trait outside of meditation so that the meditator starts to notice a background pure, non-involved witnessing state at all times, in all situations, even when sleeping or dreaming, and that this “witnessing” is consistent enough that they have started to identify their “real” self in terms of uninvolved witnessing attribute, rather than the normal transitory thoughts, feelings, desires, beliefs, etc. that most people call their “self.”

Studies on the psychological and physiological profiles of people who report this state continuously for at least a year have been published in peer reviewed journals within the past half decade.

However, reports of this state surfaced years before formal research was published. Richard Castillo reported that 6 of his patients who had been practicing TM for 1 -10 years were complaining of a state of permanent depersonalization. After interviewing them, he realized that their only complaint was concerning the unexpected existence of this unusual state and his report suggested that in the case of meditation practitioners reporting such a state who showed no signs of pathology, that they be reminded that within the context of their spiritual tradition, such a state is generally considered good.

The DSM-IV-tr now follows that suggestion: “Voluntarily induced experiences of depersonalization or derealization form part of meditative and trance practices that are prevalent in many religions and cultures and should not be confused with Depersonalization Disorder.” p. 488. (quoted at: http://www.spiritualcompetency.com/dsm4/lesson3_5.html).

Cult-therapist Margaret Singer simply assumed that anyone reporting anything as a result of what she deemed a cult practice is automatically a victim, and she reports that “victims of the TM cult have permanent depersonalization so severe that even repeated electro-shock therapy cannot cure them.”

Ironically, TM theory asserts that the normal human condition, if one is sufficiently stable and low stress, is this “first kind” of enlightenment, and that once it becomes stable, no non-fatal stress (including electro-shock therapy, apparently) will ever cause the enlightened person to become unenlightened. That this might be a good thing, despite Margaret Singer’s characterization, can be seen by the finding that world champion athletes, that is, those who compete at the world level and consistently rank in the top 10 in their events, show more of the physiological and psychological traits of enlightenment then their fellow world-level athletes who rank in the lower 50th percentile.

So again: there are plenty of people who have become at least somewhat enlightened via TM, as documented in peer reviewed research, and a report cited by the DSM-iv to justify their exception to a Depersonalization Disorder diagnosis.

Having made several posts here I would like to make one more for clarification. I am in no way shape or form a scientist and can hardly make heads or tails of scientific data presented in such papers as the one referenced in this blog.

I am a former admitted TM “junkie” who once thought the Maharishi and his organization could do no wrong. I have worked for the TM movement over a period of years and found the officials and even mid to low level managers of the Movement are nearly to a person not reliable. I have experienced underhanded and unpleasant behavior on their part first hand and know they are quite capable of doing all in their power to make TM look good to the public and keep getting grants from the federal government (or whoever else will give them money.)

Most importantly I think everyone should know that since the death of their leader the TM Movement in collusion with the David Lynch Foundation is engaging in a carefully orchestrated push to brighten the image of TM to get their deflating bank accounts full again.

A quick internet search on TM will show that in just the last few months article after article has been appearing in various magazines and online about the wonders of TM. You will also find that David Lynch and many celebrities are stumping for TM – Soledad Obrien interviews Bob Roth (long time TM spokesperson and now vice chairman of the David Lynch Foundation).

The appearances of these celebrities, the TV interviews and news articles are not appearing by chance. The TM Movement has capitalized on the immense amount of free publicity that Oprah Winfrey gave them when she announced she does TM and went to their university in Iowa. They are attempting to sanitize the image of TM by getting back to the kind of pr that was done on TM in the 1970’s – i.e. touting its beneficial effects on the human mind and body with what they call incontrovertible scientific facts.

They are deliberately moving away from publicizing the fact that they claim to also teach levitation (among other superpowers) to be able to create world peace by having large groups of people “flying” together.
Maharishi and one of his top notch scientists, John Hagelin, asked the world to give them one billion dollars back in 2001 to do just that.

The TM folks are also not being too high profile in their recent advertising when it comes to talking about the Maharishi’s last push to create new knowledge which was the vedic architecture or sthapatya veda. This is a sort of Hindu feng shui that as Maharishi interpreted it avers that having a south facing entrance in a building will cause untold problems in health, finances and relationships.

I quote the following from one of the TM Movement’s websites:

“Unless homes and working places are in harmony with the Natural Law that harmonizes everything in creation and maintains order in the whole expanding universe, the life of the individual will always remain off balance. Lack of balance between the individual and his Cosmic Counterparts will always be the basic cause of ill health, problems, and misfortune.”

The life of the individual will always remain off balance? I see no other way to interpret this than that it means no matter what you do, including regular practice of the TM, you are still going to have an unbalanced life unless you live in a Maharishi Sthapatya Veda home.

Which either means the entire the TM program is useless and ineffective, or they are lying about the necessity for this type of architecture in the world.

I am not a scientist but I do know who has credibility and the TM Movement in my mind does not.

I will also point out that it is well known among those of us who have done TM for years that the TM Movement has people who look on the internet for anyone posting anything “negative” about TM and those people, sometimes under false names, then post rebuttals on the web site or blog to spiff up the image of TM, often posting as if they are not TM teachers but just regular folks who see the reasonablness of the TM studies that are being maligned.

All I want is for people to see the whole picture and not a snapshot those who stand to gain money through teaching TM to the masses would like people to see. Then everyone is welcome to make their own assessment and do TM or not as they see fit.

I know many TM insiders, and Michael H. Jackson speaks the truth. I found it really humorous recently when some TM insiders were going on and on about how bogus Scientology is and how silly of anyone to believe it and can you believe their techniques of recruiting celebrities etc? It just shows how effective the TM brainwashing technique is that they couldn’t see AT ALL how closely the TM approach mirrors that of the scientologists. They know and keep track of every single celebrity who meditates. I am sick of hearing it. Why should I care which celebrities meditate? What has that got to do with my personal growth?

Thank you, Larry, for following this story. I really don’t see why my tax dollars should go to studying a religion for the purposes of medicine.

The real problem with all of these studies is that they don’t compare TM to an intervention program that is highly similar but not identical. For example, a program that also allows people to check in with a teacher everyday. Or a program that gives mantras, but not Sanskrit ones.

TM is obsessive about trademarking itself as the “best” form of meditation but it has never undergone a study against a very similar meditation regime. If it did, we would see that trademarking the ability to relax and calm the mind is ridiculous. Why should I pay $1,500 to learn to breathe? It’s a pyramid scheme.

Actually, such a study has been done. TM was compared with mindfulness and Benson’s Relaxation Response in a study conducted by proponents of each of the meditation techniques. The teaching of each technique was designed to instill the same expectations as gained during TM instruction. The meditation instructors made professional-looking presentations complete with charts created from real scientific studies on each technique, etc.

As an aside, TM instruction is over a period of 4 days, and now comes with a formal followup of about 1/2 hour weekly for the first month, and 1/2 hour monthly for the first year, with a free lifetime followup. I don’t believe that such a formal followup program was in effect at the time this study was performed, or it would have been part of the formal study design. Mindfulness meditation, these days, is typically taught in weekly sessions over a period of 8 weeks.

Interesting discussion! More research of high quality is indeed needed on different meditationtechniques. However, not much progress has been made since the exellent review by Peter H Canter in the high impact Journal BMJ (BMJ. 2003 May 17; 326(7398): 1049–1050.)http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1125975/

With respect to Transcendental Meditation his conclusion is:
Transcendental meditation has been studied extensively, but most of the research continues to be carried out by researchers directly involved in the organisation offering transcendental meditation, who seem keen to demonstrate its unique value. A meta-analysis of trials of relaxation and meditation for trait anxiety included 70 trials of meditation and showed that the 35 trials of transcendental meditation were associated with significantly larger effect sizes than other techniques. 7 However, it included uncontrolled trials, and its assertion that outcome was not sensitive to research design, type of control, or other confounders is not supported by any data. As it excluded studies of patients with psychiatric illnesses the relevance to clinical populations is unclear. An updated and independent meta-analysis of studies of meditation for anxiety is therefore much needed.

@ The dramatic reduction in both state and trait anxiety by generic transcending has been replicated using careful application of the STAI. See http://www.nsrusa.org/research.php for abstracts and citations. Further corroborating studies (example: N=44) with the same high effect size have been completed and are expected to be published over the next year or two. Natural Stress Relief (NSR) is a generic form of transcending self-taught using printed instructional materials with no teacher physically present. Nine years of experience distributing this technique throughout the world shows at least the same anecdotal rate of success (close to 100%) as Transcendental Meditation (TM).

I am curious about one thing still. And that is the status of Tammy Harshaw with regards to the TM Movement. Is she a TM meditator? A TM teacher? Does she work full time for the TM Movement?

The thing I am most curious about is this: is Tammy a scientist? I would think so given her very cogent analysis of Larry Husten’s critique of the TM paper’s publication.

If not, was it Bob Schneider or one of the other researchers who looked over the post here on Cardio Brief and gave Tammy the analysis to post on their behalf? I love what Bill Moyers always says in his reports “In the interest of full disclosure…”